University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT03777306
Multiple Myeloma (MM) patients are prone to poor quality of life (QoL) as a result of the anxiety and depression they suffer due to a poor understanding of their disease. Improving patient understanding of their illness and addressing issues that induce distress impacts QoL. This prospective, interventional study is designed to see if a structured psycho-educational program called "the myeloma pack intervention" (MPI), implemented in parallel with standard cancer treatment, can improve QoL for patients with MM.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
The purpose of this research study is to see if the MPI educational program, implemented in parallel with standard of care treatment, can improve overall quality of life (QoL) for MM patients. This program will be delivered to the study participants by multiple modes of communication including written material in a boxed pack, online tutorials, telephone and text message follow up. If they do not have online access at home, the study coordinators will arrange access for the participants at the Clinic. A health advisor will work with the physicians to coordinate their participation in the program while they are on active treatment for myeloma. The Pack Health Advisors will only give them guidance about the study and they will not provide any kind of clinical advice to the participants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be ineligible for the program if they are:
Other Exclusions:
Post randomization, all patients will take baseline survey to assess their level of stress prior to starting the educational program During the educational interventions they will receive
After 12 weeks on the program participants will re-take the surveys to assess the level of stress.
The educational intervention is similar as in ARM A except that the participants will receive standard of care for the first 12 weeks post randomization and then begin the educational intervention
Time frame: Baseline
We will measure baseline anxiety levels in MM patients prior to implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time frame: 12 weeks post intervention
We will measure anxiety levels in MM patients 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time frame: 24 weeks post intervention
We will measure anxiety levels in MM patients 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for anxiety
Time frame: Baseline
We will measure baseline depression in MM patients prior to implementation of educational program using the PROMIS assessment tool for depression
Time frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program using the PROMIS assessment tool for depression
Time frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program using the PROMIS assessment tool for depression
Time frame: Baseline
We will assess baseline patient self-efficacy for symptom management in MM patients before the implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Time frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Time frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the PROMIS assessment tool for self-Efficacy
Time frame: Baseline
We will baseline assess patient adherence to myeloma specific medication and treatment schedules in MM patients before the implementation of educational program (MPI) using the CASE Medication Adherence Index
Time frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Time frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using the CASE Medication Adherence Index
Time frame: Baseline
We will baseline QoL in MM patients before implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time frame: 12 weeks post intervention
We will assess outcomes 12 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
Time frame: 24 weeks post intervention
We will assess outcomes 24 weeks after implementation of educational program (MPI) using EORTC-QLQ-C30, and FACIT-sp-12 questionnaires
University of Alabama at Birmingham
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04975555
Acute Lymphoblastic Leukemia, Blood Protein Disorders
Birmingham, Alabama, United States
View Trial DetailsNCT05024045
B-cell Lymphoma, Blood Protein Disorders
Tucson, Arizona, United States
View Trial DetailsNCT01139476
Blood Protein Disorders, Cardiovascular Diseases
Iowa City, Iowa, United States
View Trial DetailsNCT06483139
Acute Kidney Injury, Blood Protein Disorders
Boston, Massachusetts, United States
View Trial Details